Reliability Engineer (Hardware)

Reliability Engineer (Hardware)

Location: San Jose, CA

Experience : 6+ Years

Role: 5 Days Onsite

Job Description :

• As a Staff Reliability Quality Engineer to ensure product reliability and quality within a complex medical device product through the development and execution of product reliability test plan by way of verification procedure based upon product and design specifications.
• This role will partner closely with R&D, Systems Engineering, Manufacturing, and Quality teams to ensure highly reliable robotic medical systems are designed, verified, and launched successfully.

What Your Day-To-Day Will Involve:

• Lead system-level reliability strategy and testing for complex electromechanical medical devices, ensuring robust product performance across the design lifecycle
• Apply advanced reliability engineering tools and methodologies such as Weibull analysis, Reliability Modeling, Fault Tree Analysis, Accelerated Life Testing (ALT), HALT/HASS, and structured root cause analysis to drive data-based design decisions
• Define reliability requirements, reliability growth plans, and reliability demonstration strategies for NPI programs and sustaining design changes ; devise test protocols and write test reports
• Design and execute reliability test protocols for mechanical, electrical, environmental, and software-driven subsystems across system, subsystem, and component levels.
• Partner with Systems Engineering and R&D to ensure proper linkage between design requirements, risk management, reliability verification, and validation activities.
• Drive reliability insights through analysis of field data, complaint trends, and nonconformance data to support product improvements and risk mitigation.
• Collaborate cross-functionally with R&D, Manufacturing Engineering, Supplier Quality, Regulatory Affairs, and Failure Analysis teams to resolve reliability issues and improve product robustness
• Develop and implement reliability testing infrastructure, including custom fixtures and automated test setups
• Champion a data-driven reliability culture by mentoring engineers and promoting best practices in reliability engineering and statistical analysis
• Ensure compliance with ISO 13485, FDA Quality System Regulations (21 CFR 820), and applicable regulatory standards
• Understand and adhere to the CLIENT'S BioRobotics EHS policy

The Qualifications We Need You to Possess:

• Bachelor's or Master's degree in engineering (e.g. Biomedical/Electrical/Mechanical)
• 5+ years of experience working in medical device or equivalent regulated industry demonstrative of Reliability expertise.
• Background in Capital Equipment and/or complex electromechanical and embedded software devices.
• Experience defining and executing Accelerated Life Testing (ALT), HALT/HASS, and reliability verification strategies.
• Perform reliability prediction analyses using established industry standards such as MIL-HDBK-217, Telcordia, and FIDES.
• Maintain automated testing frameworks using Python and C++ to perform testing.
• Strong analytical, problem-solving, statistical analysis and communication skills with the ability to influence cross-functional engineering teams.

The Qualifications We Would Like You to Possess

• ASQ CQE, or CRE certification preferred
• Basic machine tool and manufacturing experience a plus
• Experience with medical device testing or development a plus